The adjustment of the medical insurance drug list has started, and COVID-19 drugs and centralized drugs are expected to be included.

On August 3, the website of the National Medical Insurance Bureau released the Work Plan for the Adjustment of the National Medical Insurance Drug List in 2020 (Draft for Comment), and publicly solicited opinions from the public. The full text is as follows:

According to the Interim Measures for the Administration of Medication in Basic Medical Insurance, combined with the priorities of the management of the national medical insurance drug list in 2020, we have studied and drafted the Work Plan for the Adjustment of the national medical insurance drug list in 2020 (draft for comments), and now we are open to the public for comments. The public can put forward their opinions and suggestions before Monday, August 10, 2020, and report them to our bureau in written form or by e-mail.

Email: yysmlc@nhsa.gov.cn

Mailing address: No.2 -9, Yuetan North Street, Xicheng District, Beijing, Department of Medical Service Management, National Medical Insurance Bureau, 100830.

National Healthcare Security Administration (NHSA)

August 3, 2020

Work plan for the adjustment of national medical insurance drug list in 2020 (draft for comments)

In order to implement the decision-making arrangements of the CPC Central Committee and the State Council, further improve the level of drug protection for insured persons, and standardize the management of medical insurance drugs, according to the Social Insurance Law of People’s Republic of China (PRC), the Opinions of the Central Committee of the Communist Party of China and the State Council on Deepening the Reform of Medical Insurance System, the Interim Measures for the Administration of Medication in Basic Medical Insurance and related documents, the work plan for adjusting the national basic medical insurance drug list in 2020 (hereinafter referred to as the drug list) is hereby formulated as follows.

I. Objectives and tasks

Guided by the Supreme Leader’s Socialism with Chinese characteristics Thought in the New Era, we will fully implement the spirit of the 19th National Congress of the Communist Party of China and the 2nd, 3rd and 4th Plenary Sessions of the 19th National Congress, adhere to the people’s health as the center, continuously deepen the reform of the medical security system, establish a dynamic adjustment mechanism of the drug list, dynamically adjust the scope of the drug list according to the fund’s ability to pay, provide support for the normalization of epidemic prevention and control in COVID-19, strive to achieve more optimized drug list structure, more scientific and standardized management, more effective payment, more fair and accessible guarantee, and promote the medical insurance drug governance system and.

Second, the scope of adjustment

Considering the functional orientation of basic medical insurance, the clinical demand of drugs and the affordability of funds, the scope of drug list adjustment in 2020 is as follows:

(1) Western medicines and Chinese patent medicines outside the catalogue

Drugs that meet the provisions of Articles 7 and 8 of the Interim Measures for the Administration of Medication in Basic Medical Insurance and meet any of the following circumstances can be included in the scope of drugs to be added to the drug list in 2020.

1. Drugs for the treatment of respiratory diseases related to COVID-19.

2. Drugs included in the National Essential Drugs List (2018 Edition).

3. Drugs that are included in the list of overseas new drugs urgently needed in clinic, encouraged to copy drugs or encouraged to research and develop the list of children’s drugs, and approved for listing by the State Drug Administration before December 31, 2019.

4. The second batch of drugs selected in centralized drug procurement organized by the state.

5. During the period from January 1, 2015 to December 31, 2019, drugs (including new active ingredients and new dosage forms) approved for marketing by the State Drug Administration according to the new drug registration application procedures.

6. During the period from January 1, 2015 to December 31, 2019, according to the results of clinical trials, supplementary applications were made to and approved by the State Drug Administration, and drugs with major changes in indications and functional indications.

7. Before December 31, 2019, drugs that entered the latest version of the medical insurance drug list at or above the provincial level. Among them, the main active ingredients are listed in the "first batch of national key monitoring drugs for rational use" except.

Western medicine and Chinese patent medicine that meet the requirements of the drug list shall be declared by the enterprise according to the procedures, and will be included in the proposed new scope after being approved.

(two) western medicine and Chinese patent medicine in the catalogue.

Drugs in the drug list that meet the requirements of Articles 9 and 10 of the Interim Measures for the Administration of Medication in Basic Medical Insurance and meet any of the following circumstances can be included in the adjustment scope of the drug list in 2020.

1. Bring up the scope of listed drugs.

(1) Drugs whose drug approval documents have been revoked, revoked or cancelled by the State Drug Administration.

(2) Drugs whose risks outweigh the benefits after comprehensive consideration of clinical value, adverse reactions, drug economy and other factors.

2. Adjust the scope of payment of standard drugs.

(1) negotiated drugs that are within the validity period of the agreement and need to re-determine the payment standard according to the agreement.

(2) According to the enterprise application or expert evaluation, it is necessary to adjust the negotiated drugs with limited payment scope.

(3) Compared with other drugs in the same treatment field, the price/cost is obviously higher, and drugs that occupy more funds in recent years.

(3) Others

1. In accordance with the provisions, the qualified Chinese herbal pieces will be included in the adjustment scope.

2. Improve the drug catalogue, standardize the drug name and dosage form, and appropriately adjust the categories of drugs, catalogue classification structure, remarks and other contents.

Third, the working procedure

The adjustment of drug list in 2020 can be divided into five stages: preparation, enterprise declaration, expert review, negotiation and bidding, and publication of results:

(1) Preparatory stage (July-August 2020)

1 led by the State Medical Insurance Bureau, in conjunction with the Ministry of Industry and Information Technology, the Ministry of Finance, the State Health and Wellness Commission, National Medical Products Administration, the State Administration of Traditional Chinese Medicine to study and formulate a work plan, and determine the principles and procedures for catalogue adjustment. After soliciting opinions from the society, the plan will be announced.

2. Set up a working organization, establish a working mechanism, set up an expert database, formulate working rules, keep clean and honest, and avoid interests.

(2) Enterprise application stage (August-September 2020)

Publish the enterprise declaration guide. According to the scope of drug list adjustment in 2020, enterprises that meet the requirements are required to submit the necessary information to the National Medical Insurance Center. Review the data in form, and publicize the drugs that have passed the formal review.

(3) Expert review stage (September-October 2020)

Combined with the enterprise declaration, the establishment of drug evaluation database. Demonstrate and determine the technical points of evaluation. Organize evaluation experts to conduct evaluation, and form a list of suggestions on four aspects of drugs: newly added drugs transferred in, directly transferred out, transferred out, and adjusted limited payment scope.

(4) negotiation and bidding stage (October-November 2020)

1. Solicit the intention of relevant enterprises on the drugs to be included in the negotiation and bidding. According to the intention of the enterprise, organize it to submit negotiation (bidding) materials as required.

2. Organize measurement experts to carry out evaluation through fund measurement, pharmacoeconomics and other methods, and put forward evaluation opinions.

3. Negotiators negotiate or bid with enterprises according to the evaluation opinions, determine the unified national medical insurance payment standard, and clarify the management policies simultaneously.

(5) The stage of publishing the results (November-December 2020)

Announce the adjustment results of the drug list, release the new version of the drug list, and simultaneously clarify the management and implementation requirements.

Iv. composition and responsibilities of experts

(1) Evaluation experts

Evaluation experts are divided into comprehensive group and clinical group. The evaluation experts in the comprehensive group are composed of experts in pharmacy, pharmacoeconomics and medical insurance management who are honest, professional, familiar with and enthusiastic about medical security and voluntarily participate in the catalogue evaluation. They are mainly responsible for demonstrating and determining the technical points of drug evaluation and providing evaluation opinions for all drugs included in the evaluation scope. Clinical group review experts are recommended by relevant academic groups and industry associations, and are mainly responsible for giving opinions and suggestions on drugs in their professional fields.

(2) Measurement experts

It is composed of experts in medical insurance management and pharmacoeconomics recommended by local medical insurance departments and relevant academic groups. It is divided into fund calculation group and pharmacoeconomics group, and puts forward evaluation opinions on negotiated drugs and bidding drugs from two aspects: the impact of medical insurance fund and pharmacoeconomics evaluation.

(3) Negotiation (bidding) experts

It is composed of representatives of the medical insurance department and relevant experts, and is responsible for on-site negotiation and bidding with drug companies.

V. Supervision mechanism

(a) take the initiative to accept the supervision of all parties

Take the initiative to accept the supervision of the public, news media and pharmaceutical enterprises. Publicly release the work plan and publicize the list of drugs that meet the requirements for declaration. Set up a telephone number and email address to receive complaints and reports from all walks of life.

(B) improve the internal control mechanism

Clarify the responsibilities of jobs and personnel, improve the disciplines and norms such as information confidentiality, interest avoidance and accountability, and ensure that the catalogue adjustment work is fair, safe and orderly.

(3) Strengthen expert supervision

Establish a system of expert responsibility, interest avoidance, accountability, etc., and leave traces throughout all the evaluation and measurement work to ensure that experts put forward their opinions independently and impartially.